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04-2014 | All rights reserved
© 2014 Siemens Healthcare Diagnostics Inc.

White Paper

Evaluation of an Automated Humidity

Global Siemens Headquarters Global Siemens Healthcare ­ Global Division
Siemens AG
Wittelsbacherplatz 2
Headquarters
Siemens AG
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Check for Instrument-Read Urinalysis Strips:
80333 Muenchen Healthcare Sector Tarrytown, NY 10591-5005
Germany Henkestrasse 127
91052 Erlangen
USA
www.siemens.com/diagnostics
A Comparative Study of Three
Telephone: +49 9131 84-0
Germany
www.siemens.com/healthcare
Urinalysis Analyzers
Lawrence Crolla, PhD, Cindy Jiménez, MT (ASCP), and Pallavi Patel, MT (ASCP)
are from Northwest Community Hospital, Arlington Heights, IL.
Their study, on which this white paper is based, was funded by a grant from
Siemens Healthcare Diagnostics.

www.siemens.com/diagnostics Answers for life.

Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips:
A Comparative Study of Three Urinalysis Analyzers
Introduction
The integrity of urine strips is essential in obtaining
accurate test results. The improper handling of strips,
regardless of brand, can lead to false results and possible
incorrect diagnosis. If strip bottles are not recapped
or tightened completely, the contents can be exposed to
humidity in room air, potentially compromising strip
integrity and leading to reagent degradation and
false results.
A study by Crolla et al.1 compared three manufacturer’s
reagent strips and instruments after test strips were
exposed to room air. Room air exposure occurs if strip
containers are not closed after use as directed by the
manufacturer. This white paper reports the results of that
study, which compared the Siemens CLINITEK Status®+
Analyzer and MULTISTIX® 10SG urine strips to two other
manufacturers’ offerings.
Auto-Checks—Improving Clinical Information
and Urinalysis Workflow
Novel identification (ID) bands on the Siemens MULTISTIX® family
of urine reagent strips (Figure 1) provide a range of automatic
quality checks (Auto-Checks) when used with the CLINITEK Status
family⒜ of urine chemistry analyzers (Figure 2).
Proprietary Auto-Checks technology automatically:
• Detects test strip humidity overexposure⒝ —the analyzer does
not report results for this condition, minimizing false-positive results
•C
 hecks for common sample interferences⒞
(high specific gravity, elevated glucose, visibly bloody urine,
high pH)—the analyzer alerts to these interfering conditions
and documents if results may be impacted
• Identifies the Siemens reagent strip type—eliminating manual
data entry and saving time
⒜ CLINITEK Status® Connect, and CLINITEK Status® legacy
analyzers upgraded to version 2.0 or greater.
⒝ Only available with test strips that have the leukocyte pad.
⒞ Feature not available in the U.S.
2
Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips:
A Comparative Study of Three Urinalysis Analyzers
Materials and Methods Results and Discussion
The Crolla et al. study evaluated results generated The study by Crolla et al. evaluated the analyte
by three manufacturers’ reagent strip and performance agreement between stressed and unstressed
analyzer combinations: strips by examining the first replicate of each set tested.
This agreement was then compared to the agreement
• MULTISTIX 10 SG strips read on the CLINITEK Status+
between the results from the unstressed (control),
Analyzer (Siemens Healthcare Diagnostics)
replicate 1, and replicate 2.
• CHEMSTRIP® 10 MD strips read on the Urisys 1100®
MULTISTIX 10 SG strips read by the CLINITEK Status+
Analyzer (Roche Diagnostics)
Analyzer are designed to return an error flag rather than
• Clarity® UROCHECK strips read on the Urocheck 120 an actual result when the system detects that the strips
Analyzer (Diagnostic Test Group) have been potentially compromised due to excessive
Two sets of strips were prepared for each manufacturer. exposure to environmental humidity. More than 95% 
In set one, the bottle was opened and left exposed for (95% confidence interval: 95.9% to 99.7%) of the stressed
40-plus days to room air (22°C to 26°C) and room MULTISTIX 10 SG strips returned error flags when tested
humidity (26% to 56%) to simulate the exposure the strips on the CLINITEK Status+ Analyzer, correctly suggesting
could receive by an operator not properly closing the strip that the strips had been compromised and were no longer
container (stressed strips). The second set of bottles was suitable for use (Table 1).
left sealed until urine sample testing was conducted Table 1: Error-flagged results for unstressed and stressed
(unstressed strips). (humidity compromised) test strips, by manufacturer.
Approximately 200 patient urine samples were tested # Flagged
Percent
Manufacturer Condition Sample Size Flagged
across all three brand combinations. Sample numbers Results
Results
vary slightly because of errors/insufficient volume that
Siemens Unstressed 207 4 1.9%
occurred during testing. Table 1 details the total number
of samples tested, by manufacturer. Strips were tested Stressed 212 209 98.6%
with patient samples for the following analytes: occult Roche Unstressed 198 0 0.0%
blood, leukocytes, nitrate, protein, ketone, bilirubin, Stressed 212 0 0.0%
Figure 1:
MULTISTIX 10 SG reagent
urobilinogen, specific gravity, pH, and glucose.
Diagnostic
Unstressed 206 1 0.5%
strips with ID bands. Urine samples were tested over three months. The Test Group
samples were tested across all instrument systems in Stressed 214 1 0.5%
duplicate for each set of strips, stressed and unstressed.
These duplicate samples were run consecutively for
The flagged sample rate for environmentally stressed
each combination of strips and analyzers.
MULTISTIX 10 SG strips was 98.6%. Therefore, all
The study setting was an outpatient treatment center in subsequent analysis of stressed performance in this study
an urban area. Nursing personnel and medical assistants included only those strips manufactured by Roche and
Figure 2: completed a majority of the testing, with an occasional Diagnostic Test Group, as the Siemens strips did not
CLINITEK Status family test being conducted by a trained (ASCP) laboratorian. provide performance data post-stress.
of analyzers employs an This mix of operators simulated actual testing conditions
The performance of the unstressed strips (control
algorithm for humidity- in the center. All operators were trained and their
compromised reagent condition) was the percent agreement (both exact and ±1
competency assessed on all three analyzers before data
strip detection that helps group) between two replicates of unstressed strips for all
was collected.
ensure quality results. three manufacturers’ materials. The authors used a ±1
block scale, as this is the usual acceptable variance for
urine strips.
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Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips: Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips:
A Comparative Study of Three Urinalysis Analyzers A Comparative Study of Three Urinalysis Analyzers

The results summarized in Tables 2 and 3 demonstrate no For Diagnostic Test Group and Roche, performance of
significant difference (p>0.05) in replicate agreement environmentally stressed strips was assessed by
among the three manufacturers’ strips in an unstressed determining the percent agreement between the first
condition, using either exact or ±1 block scale. Based on replicate of the unstressed strip and the first replicate of
replicate agreement rates for unstressed strips of the the stressed strip. Results are summarized in Tables 4 and 5
other manufacturers, there were only two instances of for each of the analytes. Those analytes where the percent
significantly different % agreements for the two replicates agreement for the stressed conditions differs significantly
of unstressed strips. These instances are highlighted. from the percent agreement for the control conditions are
flagged as “Significant” (p<0.05) in the tables.

Table 2: Unstressed strips—replicate agreement (exact). Table 3: Unstressed strips­—replicate agreement (±1 group). Table 4: Performance of stressed vs. unstressed strips (exact). Table 5: Performance of stressed vs. unstressed strips (±1 group).

Percent Percent Within Second Percent Percent

Test Vendor Test Vendor Significant
Exact Agreement 1 Group Agreement Test Manufacturer Replicate Exact Within Significant
(P<0.05) Test Vendor Condition
Condition Agreement 1 group (P<0.05)
Bilirubin Diagnostic Test Group 96.1% Bilirubin Diagnostic Test Group 99.51%
Diagnostic Unstressed 96.10% Agreement
Roche 84.8% Roche 100.0% Bilirubin
Test Group Stressed 79.44% Significant Diagnostic Unstressed 99.5%
Siemens 96.6% Siemens 100.0% Bilirubin
Unstressed 84.85% Test Group Stressed 99.5%
Roche
Occult Blood Diagnostic Test Group 94.1% Occult Blood Diagnostic Test Group 99.5% Stressed 83.02% Unstressed 100.0%
Roche
Diagnostic Unstressed 94.1% Stressed 100.0%
Roche 94.4% Roche 99.5% Occult Blood
Test Group Stressed 76.5% Significant Diagnostic Unstressed 99.5%
Siemens 89.7% Siemens 100.0% Occult Blood
Unstressed 94.4% Test Group Stressed 85.9% Significant
Roche
Glucose Diagnostic Test Group 96.6% Glucose Diagnostic Test Group 99.0% Stressed 85.8% Significant Unstressed 99.5%
Roche
Roche 97.0% Roche 99.5% Diagnostic Unstressed 96.6% Stressed 95.3%
Glucose
Test Group Stressed 24.3% Significant Diagnostic Unstressed 99.0%
Siemens 97.5% Siemens 100.0% Glucose
Unstressed 97.0% Test Group Stressed 57.5% Significant
Ketone Diagnostic Test Group 96.6% Ketone Diagnostic Test Group 100.0% Roche
Stressed 70.8% Significant Unstressed 99.5%
Roche 93.9% Roche 99.5% Roche
Diagnostic Unstressed 96.6% Stressed 96.7%
Ketone
Siemens 95.1% Siemens 100.0% Test Group Stressed 21.1% Significant Diagnostic Unstressed 100.0%
Ketone
Unstressed 93.9% Test Group Stressed 100.0%
Leukocytes Diagnostic Test Group 87.3% Leukocytes Diagnostic Test Group 99.5% Roche
Stressed 77.4% Significant Unstressed 99.5%
Roche 84.3% Roche 91.4% Roche
Diagnostic Unstressed 87.3% Stressed 99.1%
Leukocytes
Siemens 88.7% Siemens 98.0% Test Group Stressed 17.4% Significant Diagnostic Unstressed 99.5%
Leukocytes
Nitrates Diagnostic Test Group 98.0% pH Diagnostic Test Group 97.6% Unstressed 84.3% Test Group Stressed 27.7% Significant
Roche
Stressed 62.3% Significant Unstressed 91.4%
Roche 96.5% Roche 99.5% Roche
Nitrates Stressed 79.2% Significant
Siemens 99.0% Siemens 99.5% Diagnostic Unstressed 98.0%
(binary Diagnostic Unstressed 97.6%
Test Group Stressed 14.1% Significant pH
pH Diagnostic Test Group 77.6% Protein Diagnostic Test Group 100.0% response) Test Group Stressed 98.6%
Roche 91.4% Roche 98.0% Unstressed 96.5% Unstressed 99.5%
Roche Roche
Stressed 11.3% Significant Stressed 99.1%
Siemens 86.2% Siemens 100.0%
Diagnostic Unstressed 77.6% Diagnostic Unstressed 100.0%
Protein Diagnostic Test Group 92.2% Specific Gravity Diagnostic Test Group 98.0% pH Protein
Test Group Stressed 66.2% Test Group Stressed 100.0%
Roche 87.9% Roche 94.9% Unstressed 91.4% Unstressed 98.0%
Roche Roche
Siemens 95.1% Siemens 96.6% Stressed 83.0% Stressed 91.5% Significant
Diagnostic Unstressed 92.2% Specific Diagnostic Unstressed 98.0%
Specific Gravity Diagnostic Test Group 80.0% Urobilinogen Diagnostic Test Group 99.0% Protein
Test Group Stressed 89.7% Gravity Test Group Stressed 98.6%
Roche 74.7% Roche 99.0%
Unstressed 87.9% Unstressed 94.9%
Roche Roche
Siemens 78.3% Siemens 98.5% Stressed 49.1% Significant Stressed 88.2%
Urobilinogen Diagnostic Test Group 92.7% Specific Diagnostic Unstressed 80.0% Diagnostic Unstressed 99.0%
Gravity Test Group Stressed 80.3% Urobilinogen
Test Group Stressed 11.3% Significant
Roche 86.4%
Unstressed 74.7% Unstressed 99.0%
Siemens 96.6% Roche Roche
Stressed 48.6% Significant Stressed 97.6%
Diagnostic Unstressed 92.7%
Urobilinogen
Test Group Stressed 7.5% Significant
Unstressed 86.4%
Roche
Stressed 33.0% Significant

4
5
Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips:
A Comparative Study of Three Urinalysis Analyzers
Nitrate tests return a binary (positive/negative) result and,
therefore, are not a candidate for analysis using the ±1
group criterion. For nitrate, Roche and Diagnostic Test
Group stressed strips had only 11.3% to 14.1% agreement
between the nitrate results from replicate 1 of the
stressed and replicate 1 of the unstressed conditions as
opposed to 96.5% to 98% agreement between the
replicates of unstressed condition (control).
For non-binary analyte responses (responses that are
numeric), the greatest percentage of disagreement
between the unstressed and stressed strips for exact block
output was observed with glucose, ketone, leukocyte, and
urobilinogen tests on both Diagnostic Test Group and
Roche strips. When the agreement criterion was expanded
to ±1 group, the disagreement was reduced to a large
extent for the Roche strips with the exception of leukocyte
(79.2% agreement) and protein (91.5% agreement), both
agreement rates still being significantly different from the
unstressed (control) agreement. For the Diagnostic Test
Group strips, the percentage agreement for glucose
(57.5%), leukocytes, (27.7%), and urobilinogen (11.3%)
remained significantly lower than their respective
unstressed conditions.
6
Based on the data for the Diagnostic Test Group and
Roche strip and analyzer combinations, there were
significant differences between stressed and unstressed
results because of exposure to room air and humidity.
The possibility then exists for an inaccurate diagnosis and
treatment based upon the erroneous results generated
from the exposed strips. The Siemens analyzer has an
automatic warning mechanism that prevents results from
being reported when humidity exposure is detected.
In this controlled study, approximately 98% of the time,
this system would have prevented inaccurate reporting
and generated an error message instead of generating
a result.
Evaluation of an Automated Humidity Check for Instrument-Read Urinalysis Strips:
Conclusion
Auto-Checks technology provided with Siemens
MULTISTIX 10 SG urinalysis strips and the CLINITEK
Status+ Analyzer allows for the automatic detection of
strips that may have been affected by excess humidity.
The CLINITEK Status+ Analyzer was able to detect
MULTISTIX 10 SG strips that had been compromised by
humidity, and prevented potentially erroneous results
from being reported.
Neither the Roche nor Diagnostic Test Group analyzers
incorporate a humidity detection system. Both of these
analyzers reported results for patient samples despite the
test strips being compromised by humidity. These
reported results are likely to be inaccurate, as analyte
results differed between exposed (stressed) and
unexposed (unstressed) test strips for the same
patient sample.
During numerous inspections of laboratories, Crolla et al.
have observed that it is not uncommon to see urine-strip
bottles with the cover ajar or completely removed. Their
study has shown the need for testing entities to strongly
enforce the individual manufacturer’s recommendation to
keep strip containers capped when strips are not being
removed for analysis. It also would be advantageous in
situations where there are multiple operators, which
makes it difficult to ascertain compliance, to use a system
that would notify the tester of a compromised strip and
not allow testing.
A Comparative Study of Three Urinalysis Analyzers
References
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check for instrument-read urinalysis strips. MLO Online. 2011;
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check-for-instrument-read-urinalysis-strips.aspx” \o
“http://www.mlo-online.com/features/201109/tips-from-the-
clinical-experts/evaluation-of-an-automated-humidity-check-for-
instrument-read-urinalysis-strips.aspx” http://www.mlo-online.
com/features/201109/tips-from-the-clinical-experts/evaluation-of-
an-automated-humidity-check-for-instrument-read-urinalysis-
strips.aspx.
2. Gallagher EJ, Schwartz E, Weinstein RS. Performance
characteristics of urine dipsticks stored in open containers.
Am J Emerg Med. 1990; 8:121-123.
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